Infections on the exterior of the human body are caused by a variety of micro-organisms, including bacteria, fungi, and molds. Many micro-organisms living on or within the body are beneficial, but others multiply rapidly and may form infections if unchecked by crowding of other micro-organisms or controlling environmental factors. Some organisms such as microscopic plants or fungi can live on the skin and obtain nourishment from dead tissues such as hair, nails, and outer skin layers. When fungi growing on the body grows out of control, an infection can result with detrimental effects to living tissue. In addition, fungal infections are communicable and individuals who frequent public swimming pools, gyms, or shower rooms are susceptible to being infected with various types of fungal infections as other infected individuals visit these public areas.
One type of external micro-organism based infection is Onychomycosis, commonly referred to as "nail fungus." Onychomycosis is an infection of the nail (i.e. unguis) and nail bed cause by pathogenic fungi, among other micro-organisms, and while not life threatening the disease can cause chronic discomfort and embarrassment. The decease attacks the nails and their growth centers making them look cracked, yellow, and highly disfigured. In acute cases, Onychomycosis can cause the nail to become old and yellow, making it easily damaged and from which subungual hemorrhages can result.
Onychomycosis is caused by a variety of micro-organisms such as dermatophytes, yeasts, and molds. However, the majority of Onychomycosis cases are caused by Fungi such as Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans and Epidermophyton floccosum. Once these micro-organisms establish subcutaneous growth, eradication with current treatments is difficult and reoccurrences of the stubborn disease is costly.
In recent years Onychomycosis has spread to a higher percentage of adults due, in part, to its contagious nature and the lack of effective medications that can quickly cure the disease once established within the nail bed. Current treatments include long-term (3-9 months) application of topical fungicidal creams in combination with systemic fungal treatment drugs such as grisoefulvin, terbinafine, Lamisil, and Sporonox. Some of the systemic treatments have undesirable side effects such as nausea, headache, photosensitivity, and gastrointestinal intolerance, making the process of eradication difficult and troublesome.
It is also noted that systemic fungal treatments are expensive. A treatment program using Lamisil tablets (250 mg) costs over $600 and a therapy using Sporonox can cost between $600 and $1,200. Conversely, the instant invention contemplates a non-systemic treatment program costing under $50.
Part of the difficulty of quickly curing Onychomycosis is the inability to deliver effective anti-fungal agents to the pathogenically active areas such that all of the pathogenic fungus is eradicated. Without full eradication, reoccurrence is likely, necessitating a new cycle of combined topical and systemic treatments, with the aforementioned systemic side effects. Treatment is complicated by the fact that the cutaneous nail shell is not easily penetrated and treatments of infected areas often require thinning of the nail to allow better penetration of anti-fungal agents. The nail acts as a protective barrier under which fungus can grow unhindered and even acts as a vessel for spreading the disease. Current topical anti-fungal ointments and solutions used to treat Onychomycosis do not penetrate into the nail bed easily and tend to leave some portion of fungus alive after treatment causing reoccurrence of the disease. Heretofore, the medical industry has not produced a topical treatment having the necessary chemical properties to effectively pass through the hard cutaneous nail shell and penetrate into the nail bed for rapid and complete destruction of the fungal infection.
Therefore, there is a need for a topical solution that quickly and thoroughly penetrates the nail shell, underlying nail bed, and surrounding nail tissue to deliver an effective anti-fungal agent that will kill the causes of Onychomycosis.